Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mm
- Primary DI
- 00816389028999
- Brand
- Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mm
- Company
- VARIAN MEDICAL SYSTEMS, INC.
- Model
- GM11014170
- Catalog number
- GM11014170
- Published
- 2026-05-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| JAQ | System, applicator, radionuclide, remote-controlled |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Radiology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K252717 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816389028999 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816389028999 | 00816389028999 | 816389028999 | 0816389028999 |
GMDN Terms
| Term | Definition |
|---|---|
| Anorectal brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus. It is designed for temporary implantation within the rectum and/or anus and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of anorectal applicators, e.g., hollow needles, tubes, or catheters, and their associated components. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 009120817
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816389020191 | Applicator and Dilator for Proctoscope ø26 mm | GM11014310 | GM11014310 | 2026-05-26 |
| 00816389020207 | Applicator and Dilator for Proctoscope ø30 mm | GM11014410 | GM11014410 | 2026-05-26 |
| 00816389028098 | Applicator ø 20 mm, for Proctoscope ø 26 mm | GM11014110 | GM11014110 | 2026-05-26 |
| 00816389028104 | Proctoscope ø 26 mm | GM11014120 | GM11014120 | 2026-05-26 |
| 00816389028111 | Dilator for Proctoscope ø 26 mm | GM11014130 | GM11014130 | 2026-05-26 |
| 00816389028128 | Illumination Adapter for Proctoscope ø 26 mm | GM11014150 | GM11014150 | 2026-05-26 |
| 00816389028135 | Fixation Screw | GM11014160 | GM11014160 | 2026-05-26 |
| 00816389028142 | MAASTRO Rectal Applicator Set, ø 30 mm | GM11014200 | GM11014200 | 2026-05-26 |
| 00816389028159 | Applicator ø 24 mm, for Proctoscope ø 30 mm | GM11014210 | GM11014210 | 2026-05-26 |
| 00816389028166 | Proctoscope ø 30 mm | GM11014220 | GM11014220 | 2026-05-26 |
| 00816389028173 | Dilator for Proctoscope ø 30 mm | GM11014230 | GM11014230 | 2026-05-26 |
| 00816389028180 | Illumination Adapter for Proctoscope ø 30 mm | GM11014250 | GM11014250 | 2026-05-26 |
| 00816389029002 | Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mm | GM11014270 | GM11014270 | 2026-05-26 |
| 00857235006082 | Halcyon | 5.0 | 2026-01-26 | |
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| 00858086006771 | TrueBeam | 4.0 | 2026-01-15 | |
| 00858086006788 | VitalBeam | 4.0 | 2026-01-15 | |
| 00858086006795 | EDGE | 4.0 | 2026-01-15 | |
| 00858086006825 | TrueBeam STx | 4.0 | 2026-01-15 | |
| 00899475002110 | High-Definition 120 Multileaf Collimator | 8.1 | 2016-09-10 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00816389020191 | Applicator and Dilator for Proctoscope ø26 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389020207 | Applicator and Dilator for Proctoscope ø30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028098 | Applicator ø 20 mm, for Proctoscope ø 26 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028104 | Proctoscope ø 26 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028111 | Dilator for Proctoscope ø 26 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028128 | Illumination Adapter for Proctoscope ø 26 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028135 | Fixation Screw | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028142 | MAASTRO Rectal Applicator Set, ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028159 | Applicator ø 24 mm, for Proctoscope ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028166 | Proctoscope ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028173 | Dilator for Proctoscope ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389028180 | Illumination Adapter for Proctoscope ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00816389029002 | Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2026-05-26 |
| 00810563022629 | Guiding tube 60 degrees ring for central needle | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028937 | Guided Aarhus Applicator Set | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028944 | Guided Aarhus vaginal template 60 degrees,ø 28 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028951 | Guided Aarhus vaginal template 60 degrees, ø 32 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028968 | Guided Aarhus vaginal template 60 degrees, ø 36 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028975 | Guide tube collector for up to 7 needles | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00816389028982 | Guide tube collector for up to 11 needles | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-11-25 |
| 00810563022957 | Titanium Flexible Geometry FSD Applicator Set | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-05-22 |
| 00810563022995 | Ovoid pair, mini ø 16 mm | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-05-22 |
| 00810563023008 | Ovoid mini Ø16 mm Left | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-05-22 |
| 00810563023015 | Ovoid mini Ø16 mm Right | VARIAN MEDICAL SYSTEMS, INC. | JAQ | 2025-05-22 |
| 00810563023022 | Titanium Allen wrench | Varian Medical Systems Deutschland GmbH | JAQ | 2025-05-21 |
| 00816389027961 | Interstitial mini ovoid pair, with fixation for guide tubes | Varian Medical Systems Deutschland GmbH | JAQ | 2025-05-21 |
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